This invention relates generally to inhalation devices and more particularly to personal inhalation devices having regulated operation.
The term “personal inhalation device” refers to a device that delivers doses of one or more substances, chemicals, medicines, ingredients or the like (hereinafter referred to as “deliverables”) by way of inhaled vapor. Generally, a personal inhalation device holds a medium (such as a solution) that contains the deliverable and is atomized when a user draws or puffs on the device, thereby creating a vapor containing the deliverable. The vapor and the deliverable are inhaled by the user. For the sake of clarity, as used herein, the term “inhale” refers to a person drawing in a substance (typically via the mouth but could also be via the nose, a tracheostomy, or the like) and can include, but does not necessarily require, the substance entering the lungs. As used herein, the term “vapor” refers to both a substance in the gaseous state and a suspension of finely divided solid particles or liquid droplets in a gas, including aerosols, mists and the like.
While a wide variety of deliverables are possible, personal inhalation devices are often used to deliver nicotine by inhalation, and when so used are sometimes referred to as an “electronic cigarette” or “e-cigarette.” Such devices provide several advantages as an alternative to smoked tobacco products. Inhaling a vapor containing nicotine is believed to preclude the tar and other harmful effects of traditional tobacco smoke. Also, the vapor, which dissipates quickly, reduces the hazards of secondhand smoke or passive smoking among bystanders. And because there is no actual combustion involved, personal inhalation devices avoid the fire hazard and environmental problems associated with tobacco smoking. Personal inhalation devices also have an advantage with respect to other alternative nicotine delivery systems (e.g., nicotine chewing gum, nicotine patches, etc.) in that inhaling the vapor can produce a flavor and physical sensation similar to that of inhaled tobacco smoke.
Despite these advantages, some regulatory agencies have questioned using personal inhalation devices to deliver nicotine, particularly raising concerns about the uncontrolled and inconsistent amounts of nicotine delivered by such devices. Some jurisdictions around the world have placed limits on—or even banned—the use of electronic cigarettes. In the United States, the sale and use of personal inhalation devices might require approval of the Food and Drug Administration.
Accordingly, it is desirable to provide a personal inhalation device that is more likely to gain regulatory approval.